Last Updated : January 3, 2025
Details
FilesGeneric Name:
elafibranor
Project Status:
Active
Therapeutic Area:
Primary biliary cholangitis (PBC)
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0865-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ipsen Biopharmaceuticals Canada Inc. requests that elafibranor be funded as
per the anticipated Health Canada indication.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Elafibranor is anticipated to be approved by Health Canada for the treatment of
primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid
(UDCA) in adults with an inadequate response to UDCA, or as monotherapy in
adults unable to tolerate UDCA.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | October 18, 2024 |
|---|---|
| Call for patient/clinician input closed | December 13, 2024 |
| Submission received | November 27, 2024 |
| Submission accepted | December 11, 2024 |
| Review initiated | December 12, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | March 06, 2025 |
| Deadline for sponsors comments | March 18, 2025 |
| CADTH review report(s) and responses to comments provided to sponsor | April 09, 2025 |
| Expert committee meeting (initial) | April 23, 2025 |
| Draft recommendation issued to sponsor | May 05, 2025 To May 07, 2025 |
| Draft recommendation posted for stakeholder feedback | May 15, 2025 |
| End of feedback period | May 30, 2025 |
Files
Last Updated : January 3, 2025